New legislation

Bill 7735: Patent applications related to Brazilian biodiversity

Even though Brazil has one of the biggest biodiversity worldwide, considering plant species, animals and microorganisms, not much is known about this biodiversity and, only just now researches has been carried out involving biological species native from Brazil. This reflects on the number of patent applications directly or indirectly which bear relations to the species of living beings native from Brazil or biological substances stemming therefrom.

One of the reasons emanating from this scenario is the Provisional Presidential Decree (MP2186/01), which, at the present time, deals with the Genetic Heritage on the protection and access to the traditional knowledge, in the share of benefits for the conservation and sustainable use of the native biodiversity in Brazil.

MP2186/01 has been bitterly criticized on the part of the Academic and Industrial Environment in our Country ever since its enactment. The widespread criticism falls mainly on the red tape for a person or a company to be allowed access to the samples of the natural biological diversity (living beings or part thereof), and, just as well, respecting their transportation from one place to another within the Country. On the other hand, the transportation of the samples overseas requires an even more complicated red tape.

Nowadays, for instance, a researcher or a Company wishing to research a plant species belonging to the national genetic heritage must obtain a number of licenses therefor. For the species belonging to the Associated Traditional Knowledge, the license must be petitioned along with a previous agreement of share of the benefits. In practice, the obtainment of these licenses, in many cases, takes a long time, causing the failure to carry through the research prospects in the area of the natural products in Brazil, for small businesses and startups, for example.

However, the National Congress is in the process of passing a resolution in the PL 7735/204, which amends aforesaid MP21186/01, regulates and facilitates the access and transportation of living beings or part thereof, owned by the national genetic heritage and by the traditional associated knowledge. Through the PL in debate, the licenses shall be replaced by a previous self-declaration of access on the part of the researcher or company.

The PL further deals with the functions of the Genetic Heritage Council (CGEN) affording that Agency a competency clearer than the one afforded by the MP. Among them, the CGEN is responsible for coordinating the Group in charge of preparing the List of Classification for the Breakdown of Benefits, which shall contain information on what is traditionally known in Brazil, respecting the use of plants, herbs, teas and even animals on the part of the indigenous and quilombola communities, and other communities holding traditional knowledge in the Country. The list is a well-thought artifice similar to what occurs in other countries, for instance, in India, and must be produced concurrently by the Ministry of the Environment (MMA), Ministry of the Development, Industry and Foreign Commerce (MDIC), Ministry of the Sciences, Technology and Innovation (MCTI) and performers of the Brazilian Civil Society, taking into consideration the MERCOSUR treaty.

Other innovations of the PL concern the share of traditional knowledge on the part of the Small Business Companies, startups, and small individual entrepreneurs and the attenuation of the penalties involving those individual offenders.

We believe that, if approved, PL 7735 /2014 will afford a greater legal security to the Researchers, Research Institutes, Universities and National Companies interested in researching the Brazilian Biodiversity riches and, else, developing new products from this biodiversity. Hence, in this regard, consequent upon this increase, we believe that the number of patent applications contemplating products stemming from this biodiversity will considerably increase.